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Alnylam Seeking Lumasiran Approvals Soon, But Has Two Rivals On Its Heels

 
• By Mandy Jackson

Phase III results support early 2020 filings for what could be the RNAi specialist’s third commercial product, but two competing drugs for primary hyperoxaluria from Dicerna and OxThera aren’t far behind. 

Kidney
Primary hyperoxaluria type 1 causes kidney stones and renal disease. • Source: Shutterstock

Alnylam Pharmaceuticals Inc. is ending a very good year for the company on a high note with positive Phase III results for what may become its third commercial product – lumasiran, an RNA interference (RNAi) drug for the treatment of primary hyperoxaluria type 1 (PH1). Alnylam plans to seek approvals in the US and EU early next year, which could mean a late 2020 US launch.

The Cambridge, MA-based company’s stock has risen 65% this year based on sales for its first approved drug, Onpattro (patisiran), bolstered by the approval of its second product Givlaari (givosiran) and positive results from multiple candidates in the RNAi specialist’s research and development pipeline. However, Alnylam’s share price wavered, closing down 3% at $116

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